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In the Land of the Living Logistics

Ideal drug manufacturing and logistic processes are closed and automated to eliminate the risks associated with human intervention and manual operations, but most cell and gene therapies are not yet at this stage. Here, we discuss the problems of handling living, breathing cells in transit, and ask a big question: are healthcare systems ready for cell and gene therapies?

James Strachan
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01/22/2019

In The Medicine Maker, we often discuss the challenges of scaling up and commercializing biologic drugs, such as monoclonal antibodies. Identifying the right set of conditions to get the highest titer possible, while ensuring there’s enough “wiggle room” should anything deviate, isn’t easy. But at least the cells are, in theory, identical, and there are established precedents to build processes upon. Cell and gene therapies are a whole new kettle of fish: every process is different because the cells are different, and companies are often inventing processes from scratch.

Developing and delivering cell and gene therapies necessitates the handling of living, breathing cells in transit – sometimes across great distances. You have to know exactly where your cells are at all times, who they belong to, and who has handled them. Often, you’ll have to coordinate the activities of multiple clinical centers too: condition the patient, book the bed, align your clinicians, and get the delivery in all at the right time. One mishap could mean a seriously ill patient missing their treatment, and the loss of hundreds of thousands of dollars’ worth of product.

Welcome to the world of cell and gene therapy logistics! Here, four esteemed experts in the field explore the challenges in more detail.

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About the Author

James Strachan

Over the course of my Biomedical Sciences degree it dawned on me that my goal of becoming a scientist didn’t quite mesh with my lack of affinity for lab work. Thinking on my decision to pursue biology rather than English at age 15 – despite an aptitude for the latter – I realized that science writing was a way to combine what I loved with what I was good at.

From there I set out to gather as much freelancing experience as I could, spending 2 years developing scientific content for International Innovation, before completing an MSc in Science Communication. After gaining invaluable experience in supporting the communications efforts of CERN and IN-PART, I joined Texere – where I am focused on producing consistently engaging, cutting-edge and innovative content for our specialist audiences around the world.